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The study deals with the prevalence of insomnia after heart surgery and the outcome of treatment with Benzodiazepine for this phenomena.
Patients after heart surgery develop sleep disorder in the form of Insomnia. This finding is known and described in the literature with respect to a large number of major operations such as the pneumonectomy, esophageal resection, pancreatic surgery, liver surgery and so on. In the general population, Insomnia is a common disorder and describe in more than 50% in adults over the age of 50. In patients with comorbidity among other things, heart disease indicates a rate of up to 85% of chronic insomnia. The reasons for insomnia after multiple heart surgery, including emotional stress that accompanies the patient after surgery, pain and prolonged hospitalization in the hospital. In this study, aim to compare the results of short-term treatment with sleep medication after heart surgery on morbidity and immediate recovery. This study will allow us to examine the effect of sleep medication therapy in patients receiving treatment compared to patients who did not receive treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| benzodiazepine | Experimental | The patient which will be in the Experimental arm (after randomization) will receive 0.25 mg of Brotizolam (short acting benzodiazepine) for six weeks from the day of discharge. |
|
| placebo | Placebo Comparator | The patient which will be in the placebo arm (after randomization) will receive placebo for six weeks from the day of discharge. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brotizolam | Drug | Every patient which will enroll to the study will fill up The Pittsburgh Sleep Quality Index in there admission to the cardiac surgery unit. in the discharge day the patient will receive 0.25 mg brotizolam once a day before sleep for six weeks. one week and six weeks after discharge day, there is routine follow up in our outpatient clinic. in those appointed time the patient will fill again The Pittsburgh Sleep Quality Index. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessing chronic insomnia | The following outcome will be evaluated by Pittsburgh sleep quality index questionnaire before heart surgery. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Reducing insomnia in post cardiac surgery | The following outcome will be evaluated by Pittsburgh sleep quality index questionnaire after heart surgery. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
patients who came to emergency heart surgery.
patients who are not hemodynamically or respiratory stable
Patients who were taking hypnotic drugs on a daily basis before surgery.
Patients with low compliance that will not be able to fill out a sleep diary
lactose intolerance (due to components placebo)
Patients who can not take medication by one or more of the following:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| tom mr fridman, MD | Contact | 0542220892 | tomalach@gmail.com | |
| daniel ms haber, MA | Contact | 0526138901 | d_haber@rambam.health.gov.il |
| Name | Affiliation | Role |
|---|---|---|
| gil mr bolotin, MD | Rambam Health Care Campus | Principal Investigator |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C020960 | brotizolam |
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| placebo | Drug | Every patient which will enroll to the study will fill up The Pittsburgh Sleep Quality Index in there admission to the cardiac surgery unit. in the discharge day the patient will receive 0.25 mg LACTOSE once a day before sleep for six weeks. one week and six weeks after discharge day, there is routine follow up in our outpatient clinic. in those appointed time the patient will fill again The Pittsburgh Sleep Quality Index. |
|
| D001523 |
| Mental Disorders |